Negative Beta Glucan in ICU Patients

NCT ID: NCT01734525

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-12-31

Brief Summary

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.

Therefore, the objectives of this study are:

1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;

2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Detailed Description

Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.

Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.

If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.

Conditions

Candidemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anidulafungin

Patients at risk will receive therapy with anidulafungin

Group Type: EXPERIMENTAL

Anidulafungin

Intervention Type: DRUG

Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Interventions

Anidulafungin

Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• In the ICU for >2 days AND

• Systemic antibiotics on days 1-3 of ICU OR
• Central venous catheter on days 1-3 of ICU
• AND at least 2 of:

• Total parenteral nutrition on days 1-3 of ICU
• Any dialysis on days 1-3 of ICU
• Major surgery in the 7 days before admission in the ICU
• Pancreatitis in the 7 days before admission in the ICU
• Use of corticosteroids for at least 3 days in the 7 days before admission
• Use of other immunosuppressive agents in the 7 days before admission in the ICU
• In addition, the patient must have at least one of the following:

• Fever (axillary temperature >37.5 oC)
• Hypothermia (axillary temperature <35 oC)
• Hypotension
• Unexplained acidosis
• Unexplained elevation in C-reactive protein

Exclusion Criteria

• Antifungal for >3 days
• Allergy to an echinocandin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Marcio Nucci

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcio Nucci, MD

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Locations

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Nucci M, Nouer SA, Esteves P, Guimaraes T, Breda G, de Miranda BG, Queiroz-Telles F, Colombo AL. Discontinuation of empirical antifungal therapy in ICU patients using 1,3-beta-d-glucan. J Antimicrob Chemother. 2016 Sep;71(9):2628-33. doi: 10.1093/jac/dkw188. Epub 2016 Jun 10.

Reference Type: DERIVED

PMID: 27287231 (View on PubMed)

Other Identifiers

Early Therapy

Identifier Type: -

Identifier Source: org_study_id